Operating room lead connector

ABSTRACT

An operating room connector is used in conjunction with a multiple electrode SCS system which can easily detach and connect to an external trial stimulator (ETS). By connecting the electrode SCS system to a stylet handle, and then locking the stylet handle within a slot of the connector platform, a user is able to minimize the required steps in connecting the ETS to the implanted SCS lead system. The ETS can then be used to readjust the position of the electrode array(s) previously implanted to deliver an optimal stimulation therapy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This utility patent application is a Continuation of allowed U.S. patentapplication Ser. No. 11/192,257, filed on Jul. 28, 2005, whichapplication claimed the benefit of the U.S. Provisional PatentApplication Ser. No. 60/598,813, filed Aug. 4, 2004, the benefits ofwhich are claimed under 35 U.S.C. §120, and are further incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to medical lead systems and, moreparticularly, to a connector system used with medical stimulating leadsand external trial stimulators.

BACKGROUND OF THE INVENTION

The term “lead” will be used herein to describe a plurality of elongateconductors covered by insulation. At a distal end of the lead, eachconductor is connected to an exposed (non-insulated) electrode, orelectrode contact, which is adapted to provide an electrical interfacewith the tissue that is to be stimulated. At a proximal end of the lead,each conductor is connected to an exposed terminal, which terminal isadapted to provide an electrical interface with a pulse generator, orwith a connector of an extension lead that connects with a pulsegenerator. The pulse generator may be an implantable pulse generator(IPG) or an external trial stimulator (ETS), as explained hereinafter.The term “electrode array” will refer to that portion of the lead havinga plurality of spaced-apart electrode contacts. The terms “electrode”and “electrode array” will be used herein interchangeably. At theproximal end of the lead, a plurality of electrical contacts, orterminals, can be connected directly to an implantable pulse generator(IPG), or as required depending upon the location where the IPG isimplanted, to an electrical connector of one or more lead extensions,which lead extension(s) can be connected to the IPG. The electrodecontacts on the distal end of the lead interface with tissue and candeliver a current from the IPG which causes the tissue to be stimulated.In the instance where an external trial stimulator (ETS) is required,the lead extension(s) can be connected to another type of electricalconnector, referred to as an operating room (OR) connector, or trialconnector, which OR or trial connector is part of or connected to anoperating room (OR) cable. The OR cable can then be connected to an ETS,or similar medical equipment. The electrode contacts on the distal endof the lead interface with tissue and can deliver a current from the ETSwhich cause the tissue to be stimulated.

A clinical method that is well accepted in the medical field forreducing pain in certain populations of patients is known as Spinal CordStimulation (SCS). An SCS system typically includes an implanted pulsegenerator and leads, which leads are comprised of lead wires, andelectrode contacts that are connected thereto. The pulse generatorgenerates electrical pulses that are delivered to the dorsal columnwithin the spinal cord through the electrode contacts which areimplanted along the dura of the spinal cord. In a typical situation, theattached leads exit the spinal cord and are tunneled around the torso ofthe patient to a subcutaneous pocket where the pulse generator isimplanted. Representative spinal cord stimulation systems are disclosedin the following patents: U.S. Pat. Nos. 3,646,940; 3,724,467;3,822,708; 4;338,945; 4,379,462; 5,121,754; 5,417,719; 5,501,703;6,516,227; and 6,895,280, which patents are incorporated herein byreference.

Electrode arrays currently used with known SCS systems may employbetween one and sixteen electrode contacts on a distal end of a lead orleads. Electrode contacts are selectively programmed to act as anodes,cathodes, or disconnected (turned off), creating an electrodeconfiguration. The number of electrode configurations available,combined with the ability of pulse-generating circuits to generate avariety of complex stimulation pulses, presents a huge selection ofstimulation parameter sets to the clinician. When an SCS system isimplanted, a “fitting” procedure is performed to select an effectivestimulation parameter set for a particular patient. Such a session ofapplying various stimulation parameters and electrode configurations maybe referred to as a “fitting” or “programming” session. Additionally, aseries of electrode configurations to be applied to a patient may beorganized in a steering programmable table or in another suitablemanner.

In order to achieve an effective result from spinal cord stimulation,the lead or leads may be placed in a location such that the electricalstimulation will create a stimulation felt by the patient known asparesthesia. The paresthesia induced by the stimulation and perceived bythe patient should be located in approximately the same place in thepatient's body as the pain that is the target of treatment. If a lead isnot correctly positioned, it is possible that the patient will receivelittle or no benefit from an implanted SCS system. Thus, correct leadplacement can mean the difference between effective and ineffective paintherapy.

In order to test the effectiveness on a particular patient of variousstimulation parameters and electrode configurations, it is oftennecessary to connect the lead or leads to an ETS to optimize theposition of the electrode array along the dura of the spinal cord.During this intra-operative procedure, the proximal end of the lead orlead extension needs to easily connect to an intermediate operating room(OR) cable and thereafter to an ETS.

An ETS is an external device that replicates some or all of the IPG'sfunctions and is used to evaluate the efficacy of the proposed therapy.An ETS typically includes a diagnostics module used to provide valuablefeedback to the user (physician, clinician, or patient). The user canthen determine whether the implanted lead is operational in deliveringstimulation therapy, is reliable, and comfortable. The user thenconcludes if readjusting the position of the implanted lead will benecessary. The ETS is externally worn for a period of typically seven toten days for evaluation purposes before implantation of the IPG. The ETSis typically applied with an adhesive patch to the skin of the patient,but may also be carried by the patient through the use of a belt clip orother form of convenient carrying pouch. Features of the ETS may alsoinclude: (a) usability in the operating room (OR) to test the electrodearray during placement, (b) a full bi-bidirectional communicationcapability with the clinician's programming (CP) system, and (c) theability to allow the patient or clinician to evaluate the stimuluslevels.

In the past, the known technology has allowed only one type of singleelectrode lead to be connected to the OR cable at a single time. Ifmultiple electrode arrays were to be implanted, the technology wouldonly allow one electrode array to be tested at a single time. Oneobvious solution would require two OR cables and two trial stimulators.The required additional equipment for testing a multiple electrode arraystimulation system would add complexity and time to the surgery. Currentlead OR connectors also require alignment procedures or multipleassembly steps before the connection is complete, which also addsadditional complexity and time to the “fitting” and or “programming”sessions.

As the electronic medical devices implanted in patients have become moresophisticated in providing a wider range of stimulation therapies whichrequire multiple electrode arrays, there has arisen a critical need fora reliable, easy-to-manufacture OR connector that allows the multipleelectrode array system to be detachably and reliably connected to anexternal trial stimulator.

It is thus evident that improvements are still needed in OR connectorsystems, particularly to facilitate connecting an external trialstimulator with a multiple electrode array system.

SUMMARY OF THE INVENTION

The teachings of the present disclosure address the above and otherneeds by providing a stimulation system and method that permitsdetachably connecting multiple implantable leads to an external trialstimulator to optimize the position of the electrode array along thespinal cord.

That is, in one aspect, the present disclosure provides an embodiment ofa connector system that provides of multiple rows of mating contactsthat can electrically connect one or more implantable leads forsimultaneous stimulation with an external trial stimulator. The multiplerows of mating contacts are enclosed within open slots on a flat surfaceof a connector platform.

In accordance with the teachings of the present disclosure, at least twoopen slots or attachment areas are made available on a flat surface of aconnector platform for purposes of detachably connecting a dualelectrode lead assembly. Three or more open slots are also possible,wherein the additional open slots would allow the user the flexibilityto have several connecting open slots available during the connectionprocess of an external trial stimulator or other similar medicalequipment.

In accordance with the teachings of the present disclosure, theconnecting open slots are substantially parallel to each other andextend along a surface of the connector platform. Spaced apart matingcontacts are provided in each slot. A stylet wire which is permanentlyattached to a stylet handle engages a lead or lead extension through acentral lumen. The stylet handle acts as a quick connect interface thatpositively locates and clips down onto any of the available parallelopen slots of the connector platform. The stylet handle also acts as acarrier which secures the plurality of spaced-apart electricalterminals, located at the proximal end of the lead within the open slot.The corresponding mating contacts along the open slot align with theplurality of spaced-apart electrical terminals, thereby allowing anelectrical connection to be made between the contacts and terminals.

In accordance with yet another feature of the invention, a stylet handleis used to house and protect the proximal electrical terminals of thelead or lead extension. The stylet handle acts as a quick connectinterface that individually locates an implantable lead onto a connectorplatform.

Another embodiment of the present invention is a method for positioninga multiple lead assembly along the dura space of a patient or othersuitable location. The multiple leads include a distal end and aproximal end. The distal end has a plurality of spaced-apart electrodecontacts and the proximal end has a plurality of spaced-apart electricalterminals. Wires carried within the body of each lead connect respectiveterminals to respective electrode contacts. Each lead is engaged with astylet wire having a stylet handle, which stylet wire may be permanentlyattached to the stylet handle. The stylet wire is threaded through acentral lumen that runs the entire length of each lead. The stylethandle interfaces with a connector platform which positively engages theplurality of electrical terminals of each lead with corresponding matingcontacts within an open slot or attachment area of the connectorplatform. An OR cable is used to connect the connector platform and theexternal trial stimulator. The distal end of the lead may berepositioned as needed with the stylet wire until enough data has beengathered from the external trial stimulator to indicate that an optimalposition for the electrode array has been established. Once an optimalposition is established, the stylet handle is disconnected from theconnector platform and the stylet wire is removed from the lead system.The lead system is then finally connected to an IPG. The IPG isthereafter used for applying current stimulation pulses to the implantedelectrode array, thereby allowing an effective stimulation therapy tothereafter commence through the use of the IPG.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features and advantages of the presentinvention will be more apparent from the following more particulardescription thereof, presented in conjunction with the followingdrawings wherein:

FIG. 1A shows a Spinal Cord Stimulation (SCS) system having an exemplarydual electrode system;

FIG. 1B depicts the SCS system of FIG. 1A implanted to stimulate tissuenear a spinal column;

FIG. 2 shows an exploded view of the various components of the SCSsystem and various components of an ETS connecting system;

FIG. 3A shows a top view of a preferred embodiment of a stylet handle ofthe present invention;

FIG. 3B is a cross sectional view of the stylet handle shown in FIG. 3Ataken along line 3B-3B;

FIG. 4A is a side view of the stylet handle shown in FIG. 3A and furthershows a stylet wire attached to the stylet handle being inserted throughthe central lumen of a lead or lead extension;

FIG. 4B is a side view of the stylet handle and stylet wire shown inFIG. 3A with the lead or lead extension positioned within the stylethandle;

FIG. 4C is a bottom view of the stylet handle and stylet wire shown inFIG. 3A with the lead or lead extension positioned within the stylethandle;

FIG. 5A is an exploded view of an exemplary embodiment of a connectorsystem of the present invention;

FIG. 5B is a perspective view of the connector system shown in FIG. 5A,with a stylet handle connected onto a first locking groove locatedwithin the connector platform of the present invention;

FIG. 6 is a perspective view of a connector system, with two stylethandles and two leads or lead extensions shown completely insertedwithin the attachment area of the connector system;

FIG. 7A is a front view of the connector system shown in FIG. 6;

FIG. 7B is a cross sectional view of the connector system taken alongsectional line 7B-7B shown in FIG. 7A; and

FIG. 8 is a flowchart depicting the steps used for positioning anelectrode array along a dura space of a patient.

Corresponding reference characters indicate corresponding componentsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best mode presently contemplated forcarrying out the invention. This description is not to be taken in alimiting sense, but is made merely for the purpose of describing thegeneral principles of the invention. The scope of the invention shouldbe determined with reference to the claims.

For illustration purposes, the following description is provided inconjunction with a Spinal Cord Stimulation (SCS) system. Other types ofstimulation systems may also be used such as, but not limited to,cochlear implants, cardiac stimulation systems, peripheral nervestimulation systems, brain stimulation systems and microstimulators. Adual SCS lead system 100 is shown in FIG. 1A. The SCS system 100typically comprises a rechargeable, multichannel, 16-contact (or more),telemetry-controlled pulse generator housed, for instance, in a roundedtitanium hermetically sealed enclosure, known as an Implantable PulseGenerator (IPG) 400. The dual SCS lead system 100 shown in FIG. 1A alsocontains two lead extensions 16A and 16B, two electrode leads 10A and10B each having an electrode array 12A and 128 at a distal end. The IPG400 generates current stimulation pulses and delivers such stimulationpulses to the plurality of implanted electrode contacts 18A and 18Bincluded with the electrode arrays 12A and 12B. The proximal end of eachlead extension 16A and 16B is removably connected to the IPG 400. Thedistal end of each lead extension 16A and 16B is removably connected toa proximal end of a corresponding electrode lead 10A or 10B using a leadconnector(s) 150. An electrode array 12A and 12B is formed on a distalend of each electrode lead 10A and 10B. The in-series combination of thelead extension 16A and electrode lead 10A, carry the stimulation currentfrom the IPG 400 to the electrode array 12A, thereby providing atingling sensation felt by the patient known as a “paresthesia.” Also,the in-series combination of the lead extension 16B and electrode lead10B, similarly carry the stimulation current from the IPG 400 to theelectrode array 12B delivering the “paresthesia.” Note, as used herein,the term “paresthesia” refers to that area or volume of the patient'stissue that is affected by the electrical stimuli applied through theplurality of electrode contacts 18A and 18B. The patient may typicallydescribe the paresthesia as an area where a tingling sensation is felt.

The SCS system 100 described in FIG. 1A, is depicted implanted in theepidural space 250 shown in FIG. 1B. The set of electrode arrays 12A and12B are implanted at the site of nerves that are the target ofstimulation, e.g., along the spinal cord 240. Due to the lack of spacenear the location where the electrode leads 10A and 10B exit the spinalcolumn, the IPG 400 is generally implanted in the abdomen, above thebuttocks, or other suitable location. The lead extensions 16A and 16Bfacilitate locating the IPG 400 away from the electrode lead exit point.

In a preferred embodiment, two or more electrode arrays 12A and 12B maybe implanted in the patient. Having a relatively greater number ofelectrode contacts increases the area of the body that can be affectedby stimulation, or the “area of potential stimulation.” The area ofpotential stimulation corresponds roughly to the area of the body mappedto the dermatomes for the area of the spine adjacent to the implantedelectrodes. The area of potential stimulation may be divided intosections, each section corresponding to the electrodes that typicallyprovide stimulation to that section of the body.

A more detailed description of a representative SCS system that may beused with the present disclosure is described in U.S. Pat. No.6,516,227, previously incorporated herein by reference. It is to beemphasized, however, that the disclosure herein described may be usedwith many different types of stimulation systems, and is not limited touse only with the representative SCS system described in the '227patent.

An external trial stimulator (ETS) 300 (shown in FIG. 2) is used withthe dual SCS lead system described above during, e.g., the first sevento ten days after implantation of the multiple lead assembly and beforeimplantation of the hermetically sealed IPG 400. The ETS 300 istypically used to test the efficacy of the electrode system, e.g., fortesting the stimulation therapy and or for fitting purposes. In thismanner, the patient can provide valuable feedback as to theeffectiveness of the stimulation therapy. The stimulus or position ofthe electrode array can change several times until a satisfactory“paresthesia” is found. After the testing period, the ETS 300 isdisconnected and surgery for implanting the IPG 400 can commence. Oncethe IPG 400 is implanted in the abdomen, above the buttocks, or anyother suitable location, the IPG 400 may be programmed to provide thepatient with his or her personalized stimulation therapy previouslyobtained during the testing period.

For medical professionals involved with the testing period, a challengeexits for connecting a multiple lead assembly to the ETS 300. Theconnecting system must not only be reliable, but also must possess amultiplicity of connecting slots that can accommodate the most currentSCS components available in the medical field.

A connecting system 200 made in accordance with one embodiment of theinvention is shown in FIG. 2. Dual lead assemblies 80 or 80′ may be usedwith the SCS system. The dual lead assemblies 80 and 80′ consist of twoelectrode arrays 12A and 12B located at the distal end of each lead 1 OAand 1 OB. Each electrode array 12A and 12B includes a plurality ofspaced-apart electrode contacts 18A and 18B, e.g., eight electrodecontacts are included within the distal end of each electrode array. Theelectrode contacts 18A and 18B are exposed to the tissue to bestimulated. At the proximal end of the lead assembly 80, two connectors150 are used to connect lead extensions 16A and 16B. The lead extensions16A and 168 contain a plurality of spaced-apart electrical terminals 14Aand 14B, which terminals connect to an implantable pulse generator (IPG)400. In contrast, the dual lead assembly 80′ does not require leadextensions 16A and 16B, since electrical terminals 14A and 14B locatedat the proximal ends of each lead 10A and 10B may be directly connectedto the IPG 400. It is to be emphasized that the dual lead assemblies 80and 80′ are only exemplary, two or more lead assemblies may be used.

The IPG 400 contains stimulating electrical circuitry (“stimulatingelectronics”), a power source, e.g., a rechargeable battery, and atelemetry system. Typically, the IPG 400 is placed in a surgically-madepocket either in the abdomen, or just at the top of the buttocks. Itmay, of course, also be implanted in other locations of the patient'sbody. Once implanted, the IPG 400 may be connected to the lead assembly80 through connecting orifices 402 and 404 located in the header portion406 of the IPG 400. The lead extensions 16A and 16B, for example, may betunneled up to the spinal column. Once implanted, the electrode arrays12A and 12B, leads 10A and 10B, and lead extensions 16A and 16B areintended to be permanent. In contrast, the IPG 400 may be replaced whenits power source fails or is no longer rechargeable. Advantageously, theIPG 400 can provide electrical stimulation to the patient through theplurality of electrode contacts.

As seen best in FIG. 2, the electrode assembly 80 typically interfaceswith the IPG 400 via a set of lead extensions 16A and 16B oralternatively, electrode assembly 80′ typically interfaces with the IPG400 without requiring lead extensions. Electrode assemblies 80 or 80′may also be connected to an external trial stimulator (ETS) 300 throughan OR cable 38 and connecting system 200. The external trial stimulator300 includes the same pulse generation circuitry as does the IPG 400,and is used on a trial basis, e.g., for 7-10 days, after the electrodearray system has been implanted, and prior to implantation of the IPG400, in order to test the effectiveness of the stimulation that is to beprovided.

Turning next to FIGS. 3A and 38, a top view of stylet handle 22A and across sectional view of the stylet handle 22A are respectively shown.The cross-sectional view is taken along line 38-38 shown in FIG. 3A. Theproximal end 23A of stylet wire 15A may be permanently attached to thestylet handle 22A at location 25A as shown in FIG. 38. Typicalattachment methods known in the art may be used, e.g., adhesive bonding,attaching the stylet wire during the molding process of the stylethandle, or heat staking (which is a bonding method for joining metalparts to plastics parts). The stylet handle is typically made from amolded plastic material, or the like, in accordance with common practicein the art. The molded part of the stylet handle includes a frontlocking member 32A and a rear locking member 35A which are used toconnect the stylet handle 22A to a connector platform 20 as explained inmore detail below.

FIG. 4A shows the proximal end of the lead 10A or lead extension 16A (alead extension 16A may or may not be required) being positioned withinthe stylet handle 22A. A stylet wire 15A is inserted through the lead'scentral lumen 17A until the proximal end of the lead is in contact withslanting edge 19A as seen best in FIG. 4B. It is to be emphasized thatthe stylet wire 15A is used to stiffen the lead during surgery, thus thestylet wire 15A runs through a central lumen along the entire length ofthe lead, including any required lead extensions. FIG. 4B shows a sideview of the plurality of electrical terminals 14A positioned within thestylet handle 22A and FIG. 4C shows a bottom view of the lead extension16A and stylet handle 22A positioned within the stylet handle 22A.

Turning next to FIG. 5A, an exemplary embodiment of a connector system200 is shown that includes a connector platform 20 and a stylet handle22A. The connector platform 20 may include a top surface 30A, anopposite bottom surface 308, a rear surface 30G, an opposite frontsurface 300, a left surface 30E, and an opposite right surface 30F.Within the connector platform 20, a plurality of spaced-apart matingcontacts 24A and 24B are located within an attachment area or open slots28A and 28B. The open slots 28A and 28B are shown being located onsurface 30A, but may alternatively be located on any of the othersurfaces 30B, 30G, 300, 30E, or 30F. The attachment area within theconnector platform 20 may also consists of closed slots or othersuitable attachment means. The proximal end of the lead 10A or leadextension 16A is inserted into the stylet handle 22A and aligned to theconnector platform 20 as shown in FIG. 5B. Mating contacts 24A alignwith the plurality of spaced-apart electrical terminals 14A, forsimultaneous stimulation with a trial stimulator 300. The stylet handle22A acts as a carrier for housing and protecting the proximal end of thelead 10A or lead extension 16A. The stylet handle 22A also acts as aquick connect interface that positively locates, locks, and unlocks intothe connector platform 20. The connector platform 20 allows two stylethandles 22A and 22B to be engaged using open slots 28A and 28Brespectively. Two exemplary open slots 28A and 28B are shown, but threeor more could be made available. The additional open slots would allowthe user the flexibility to have several engagement configurationsavailable during the connection process of the ETS 300 or similarmedical equipment.

In another aspect of the invention, open slots 28A and 28B aresubstantially parallel to each other and extend along surface 30A of theconnector 20, disposing therein spaced-apart mating contacts 24A and24B. The open slots 28A and 28B may also extend along any other surfaceof the connector 20. Stylet handle 22A is engaged along the longitudinalaxis of slot 28A. The stylet handle 22A secures the proximal end of thelead 10A or lead extension 16A within open slot 28A. Likewise, thestylet handle 22B secures the proximal end of lead 108 or lead extension168 using open slot 28B.

The connector platform 20 allows stylet handle 22A to house and protectspaced-apart electrical terminals 14A of the lead 10A or lead extension16A. The stylet handle 22A further acts as a quick connect interfacethat positively locates and clips down onto open slot 28A of connectorplatform 20 as shown in FIG. 5B, where the front locking member 32A isinitially secured onto open slot 28A. The stylet handle 22A is thenlocked in place when the rear locking member 35A snaps down onto openslot 28A. In a similar manner, the proximal end of lead 10B or leadextension 16B is likewise connected to connector platform 20 usingstylet handle 22B and open slot 28B as shown in FIG. 6.

FIG. 7A shows a front view of the connector platform 20. The lead 1 OAor lead extension 16A and stylet handle 22A are shown in their lockedand aligned position in the cross sectional view FIG. 7B, taken alongsectional line 7B-7B shown in FIG. 7A. The locking members 32A and 35Aof the stylet handle 22A are positioned along the locking grooves 33Aand 37A respectively. FIG. 7B shows a plurality of spaced-apartelectrical terminals 14A positively aligned with a row of matingcontacts 24A.

Open slots 28A and 288 can either be used to individually connect astylet handle having a lead or lead extension housed therein, or theopen slots 28A and 28B can be used as a pair, electrically connectingwith another connector platform 20. Various connecting configurationscan be obtained by having two or more parallel open slots availablewithin the connector platform 20. The main advantage is to allow amultiple lead system 80 or 80′ to be connected to an ETS 300.

Returning to FIG. 2, end 36A of the OR external cable 38, detachablyconnects to the ETS 300 through port 302A and end 36B connects to theETS through port 302B. The end 36C of the OR external cable 38detachably connects through opening 34 located on surface 30D of theconnector platform 20. Opening 34 can alternatively be located on anyother surface of the connector platform 20 depending on the orientationof the connecting slots. Alternatively, end 36C may be permanently wiredto the connector platform 20.

The simple process of connecting a proximal end of an implantable leadto a stylet handle and then locking the stylet handle to a connectorplatform allows the user the advantage of minimizing the required stepsin connecting the ETS 300 to the implanted SCS lead system. During thetesting period, the ETS 300 can then be used to (1) optimize theposition of the electrode arrays 12A and 12B along the dura of thespinal cord or other target tissue area; (2) test the efficacy of theelectrode system, e.g., test the stimulation therapy for fittingpurposes; and (3) provide valuable feedback through the use of adiagnostics module and patient interaction. After an optimal positionfor the electrode arrays 12A and 12B has been established, the stylethandles 22A and 22B may be disconnected from the connector platform 20and the stylet wires 15A and 15B may be removed from the lead system.The lead system 80 or 80′ may then be finally connected to an IPG 400,as shown in FIG. 18.

FIG. 8 shows a flowchart depicting exemplary steps for positioning anelectrode array along a dura space (or other target tissue location) ofa patient. The flowchart begins by engaging a respective stylet wire 15Aor 158 to a lead assembly, 80 or 80′ (block 502). It is to be emphasizedthat the lead assemblies 80 and 80′ are only exemplary, two or more leadassemblies may be positioned. A stylet wire is typically threaded alonga central lumen the entire length of the lead. The stylet wire stiffensthe lead while the surgeon maneuvers the lead along the dura space (orother target tissue location) of the patient (block 504). Once apreliminary position of the electrode arrays 12A and 12B has beendetermined, each stylet handle 22A and 22B are connected to a connectorplatform 20 (block 506). A cable 38 is used to connect the connectorplatform 20 to the external trial stimulator 300 (blocks 508 and 510).As required, the distal end of each lead is readjusted with respectivestylet wires 15A and 15B (block 512). Electrical current is applied tothe distal end of the lead with the external trial stimulator 300 (block514), thereby delivering stimulation current pulses to the patient(block 516). The efficacy of the electrode system is tested using, e.g.,a diagnostics module and patient interaction (block 518). If the testedresults are negative, the steps shown in blocks 512, 514, 516, and 518are repeated until the stimulation therapy is shown to provide effectiveresults (block 520). Once a satisfactory stimulation therapy has beendetermined, the stylet handles 22A and 22B are disconnected from theconnector platform 20 (block 522), the respective stylet wires 15A and15B are removed from the lead assembly (block 524), and the leadassembly is detachably connected to the IPG 400 (block 526). The IPG 400is thereafter used for applying current stimulation pulses to theimplanted electrode array (block 528). In this manner, effectivestimulation therapy can thereafter commence through the use of the IPG400 (block 530).

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the scope of the invention set forth in the claims. Forexample, the embodiments discussed above are not limited to spinal cordstimulation systems and may be used with many kinds of stimulationsystems such as, but not limited to, cochlear implants, cardiacstimulation systems, peripheral nerve stimulation systems, brainstimulation systems and microstimulators.

1. A connector for connecting at least one lead system to an externaltrial stimulator, the at least one lead system including a distal endand a proximal end, the distal end having a plurality of spaced-apartelectrode contacts and the proximal end having a plurality ofspaced-apart electrical terminals, the connector comprising: a connectorplatform having at least one open slot; and a stylet handle detachablyconnected to said connector platform inside the at least one open slot,wherein a stylet wire is permanently attached to said stylet handle, andwherein the stylet wire engages the at least one lead system through acentral lumen.